Posters

Automated Cell Line Development With Greater Than 99% Monoclonality On the Beacon® Platform

For all cell lines used in production for commercial therapeutics, FDA guidelines require assurance of monoclonality. This standard means that typical cell line development (CLD) campaigns often require multiple rounds of cloning easily spanning several weeks to months. However, Berkeley Lights, Inc. (BLI) has developed the ability to save time and money spent on CLD processes via automation. The uniquely powerful Beacon® optofluidic platform performs single-cell cloning, growth and titer measurements, and recovery of top clones with unrivaled (>99%) monoclonality…

High Titer Recombinant Lentivirus and Adeno-associated Virus Production for Therapeutic Applications

Increase your recombinant lentivirus and adeno-associated virus (AAV) production with a novel transfection formulation, TransIT-VirusGEN® Transfection Reagent, specifically designed for large-scale virus production to support gene and cell therapies. This poster highlights TransIT-VirusGEN® for use in adherent or suspension cell culture platforms along with enhancers that significantly increase functional virus titers over PEI based formulations. Testing was performed with multiple serum-free media formulations and examined using different plasmid DNA concentrations to better address compatibility within various workflows. Download the poster…

New Approach for Qualifying Liquid Handling in Single-Use Bags

2D Flexsafe® Bags and Shells Offer Strong Validation: Complete logistical solution for handling and shipping of liquid bulk drug substance in a 2D Flexsafe® bag & shell Quality by design principles Comprehensive and innovative testing program following the guidelines like ASTM, NF and ISO The system allows for safe variable shipping volumes of 10–120% of nominal fill volume and can be leveraged by the end-users for their own process validation Fill out the form below to view the complete poster…

Antibody Affinity Extraction Enables Identification of Host Cell Proteins by Mass Spectrometry

Host cell proteins (HCP) constitute a major group of impurities for biologic drugs produced using cell culture technology. Even at nanogram per milligram concentrations of HCP to drug substance (DS), HCPs can elicit undesired immune response, interfere with drug safety and efficacy, or impact DS stability. A broadly-reactive HCP ELISA should be used during the purification processes to ensure removal of HCPs and to demonstrate process consistency and final DS purity. Regulatory authorities are requesting biopharmaceutical companies employ orthogonal methods…

Step-wise strategy to address process characterization and late phase development – toward the definition of a standardized approach

Drivers for process characterization and late phase development include improving process understanding, enhancing process robustness, and assurance that the process delivers consistent product quality within all Proven Acceptable Ranges (PARs). Regulator’s expectations for biologic submissions include the application of statistical methods to improve the confidence of the PARs and knowledge of the design space for a process. Different approaches have been reported for process characterization but contain common elements including risk assessment, scale-down model qualification, and statistical design of experiments.…

Characterization and Lot Release Assays for Antibody Drug Conjugates

Antibody-drug conjugates (ADCs) add an additional level of challenge to testing of biotherapeutics. Besides the antibody, which needs to be evaluated for potential and known mechanisms of action (MoA), there is a cytostatic compound conjugated that alters the behavior of the antibody-vehicle within the typical assays. Therefore, characterization of new innovators as well as biosimilarity assessment is even more challenging than it is for antibody therapeutics. Using the example of Trastuzumab emtansine, Charles River has set up a panel of…

Keeping Host Cell Protein ELISAs Covered

Biological drugs (or biologics) are manufactured by living systems such as microorganisms, and plant and animal cells. Cell lines, like Chinese hamster ovary (CHO), can be engineered to work as cellular factories to produce biologics in addition to their own biological molecules. Host cell proteins (HCPs) are biological by-products of these cellular factories. They are one of the main impurities in harvested cell culture fluid (HCCF), and tend to be released when the cells die or are damaged. These HCPs…

Removal of Isoagglutinins from IVIG and Plasma Using Affinity Chromatography

Antibody-mediated haemolysis is a hard-to-predict phenomenon with potentially severe consequences. It is mediated by naturally-occurring anti-A and anti-B immunoglobulin isoagglutinins, which are present in plasma, blood, and several derived products, including IVIG produced by plasma fractionation. Prometic Bioseparations have developed an affinity chromatography resin for the removal of isoagglutinins from plasma and plasma derived products, such as IVIG. The resins, IsoClear A and IsoClear B, can clear isoagglutinins from a titre of 1/32 down to negative agglutination using a load…

Expansion, Recovery and Characterization of hMSCs on Dissolvable Microcarriers for Bioprocess Applications

Human mesenchymal stem cells (hMSCs) are currently the most common adult stem cell type used for cell therapy applications due to their regenerative properties and ability to differentiate into multiple cell lineages (adipocyte, chondro¬cyte, and osteocyte). Traditionally, hMSCs have been cultured on two-dimensional cell culture platforms using serum-containing medium. Although these platforms can be used successfully for small-scale expansion of hMSCs, other platforms will be required to generate the quantity of cells required to support the increasing number of clinical…

Development of a Next Generation Cellulose-Based High Capacity rProtein A Capture Resin for High Throughput MAb Purification in Both Batch and Continuous Purification Formats

A new product development approach will be described for the affinity capture of Mab’s from cell culture materials employing a novel base stable rProtein A ligand. Using a stable cellulose base bead with excellent flow properties coupled with a novel immobilization methodology, a next generation rProtein A capture resin has been developed with a high level of antibody binding capacity. The new Cellufine™ rProtein A resin shows C20% dynamic binding capacity (DBC) of >50 mg/ mL with polyclonal antibodies at…